Z-0998-2026 Class II Ongoing
FDA device recall Z-0998-2026 was initiated by Vision RT Ltd on August 27, 2025 and is designated Class II. Reason for recall: Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Ins… The recall status is ongoing. Affected quantity: 56.
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2026
- Initiation Date
- August 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 56
Product Description
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Reason for Recall
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
Distribution Pattern
U.S. and OUS
Code Information
Part Number V000629